EMEA-002124-PIP01-17 - paediatric investigation plan

Pexastimogene devacirepvec

Key facts

• Active Substance:
  Pexastimogene devacirepvec
• Therapeutic area:
  Oncology
• Decision number:
  P/0201/2017
• PIP number:
  EMEA-002124-PIP01-17
• Pharmaceutical form(s):
  Suspension for injection
• Condition(s) / indication(s):
  Treatment of hepatocellular carcinoma
• Route(s) of administration:
  Intratumoral use
• Contact for public enquiries:

  Transgene S.A.

  France; Tel. [phone]; E-mail: [e-mail]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  14/07/2017

Decision

P/0201/2017: EMA decision of 14 July 2017 on the granting of a product-specific waiver for pexastimogene devacirepvec (EMEA-002124-PIP01-17)

AdoptedReference Number: EMA/444489/2017